MI
Gestionnaire optimisant les espaces, processus et sécurité physique de Mila, pôle montréalais de recherche en IA. Coordination stratégique avec chercheurs, administration, TI et parties prenantes.
About the role
- Project Manager overseeing clinical research projects, site activities, and vendor delivery at Indero, a clinical-trials CRO. Coordinating budgets, timelines, compliance, and stakeholders.
Responsibilities
- Ensure successful initiation, planning, execution, monitoring, controlling, and closure of assigned clinical research projects
- Coordinate vendor scope, timelines, deliverables, budgets, performance, documentation, risks, issues, and escalations
- Serve as a primary contact for Sponsors, vendors, and internal teams
- Coordinate tasks and deadlines across departments
- Oversee project coordinators, SSU team members, RDA, and RAC resources for site activation prioritization
- Coordinate vendor supplies and services with site activation timelines
- Escalate at-risk site activation timelines to Project Manager II
- Manage stakeholder needs and expectations and support team training
- Plan project activities and resources and manage work and deliverable quality
- Provide project status updates and reconcile study trackers
- Analyze discrepancies and support corrective actions, change control, and risk management
- Review and assist in drafting operational plans, processes, and manuals
- Ensure study documents and deliverables meet applicable country, regulatory, SOP, GCP, and study-specific requirements
- Oversee site selection, patient recruitment, investigator meetings, regulatory submissions, essential documents, TMF reviews, and clinical monitoring support
- Maintain project training matrices and ensure team training completion
- Support sites with investigational products, study supplies, equipment, and safety lab kits
- Collaborate with Data Management on CRF compliance, query resolution, data review, and database lock timelines
- Oversee vendors throughout the project lifecycle and monitor services, performance, milestones, risks, issues, deviations, quality events, documentation, metrics, and KPIs
- Review vendor work orders, budgets, scopes of work, change orders, and invoices
- Lead or participate in vendor meetings and ensure resolution of follow-up actions
- Collaborate with subject matter experts and Quality Assurance to ensure vendor deliverables and quality requirements are met
- Maintain positive vendor relationships and vendor compliance with contractual obligations
Requirements
- B.Sc. in a related field of study to clinical research
- At least 3 years of experience in a similar role, including management of clinical studies in the pharmaceutical, biotechnology and/or CRO industry
- At least 2 years of experience coordinating clinical trial management activities
- Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations
- Excellent knowledge of Microsoft Office suite
- Excellent oral and written skills in English; French is an asset
- Experience managing small to medium projects using a disciplined approach to project management
- Demonstrated ability to establish and deliver resource-based project plans
- Experience working with and managing teams in a matrix environment
- Excellent communication, people management, problem-solving, organizational, teamwork, and pressure-management skills
- Legally authorized to work in Canada
Benefits
- Flexible work schedule
- Permanent full-time position
- Comprehensive benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
- Ongoing learning and development opportunities
- Option to work remotely anywhere in Canada or from the Montreal headquarters
- Occasional visits to the Montreal office may be required or encouraged
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Experience level
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